Actively Recruiting
Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-09-09
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
G
Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, prospective observational study focused on patients with active inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The study aims to describe changes in body composition, particularly the percentage of lean mass and phase angle, in patients who are starting biologic therapy or Janus kinase inhibitors (JAKi) to induce clinical remission. The research seeks to better understand how body composition evolves with medical treatment in these conditions. Body composition will be measured using bioelectrical impedance analysis (BIA) at three time points: at the start of treatment (baseline), at 24 weeks, and at 52 weeks after beginning medication. Clinical disease activity, endoscopic results, and laboratory data will also be collected when available. The study includes patients with ulcerative colitis and Crohn's disease and is non-interventional, with all treatments following standard clinical practice. Participants will provide informed consent and be observed over a total duration of 36 months, which includes a 12 to 18-month period for patient recruitment and a 12-month follow-up. Assessments include body composition scans and routine clinical data collection at specified intervals. The researchers will monitor changes in phase angle at 24 weeks and overall body composition changes over 24 months to evaluate the effects of medical therapy in IBD.
CONDITIONS
Brief Title
Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex.
- Age between 18 and 64 years.
- Confirmed diagnosis of Crohn's disease or ulcerative colitis for more than 3 months.
- Moderate-to-severe disease activity with planned biologic or JAKi therapy to induce remission.
You will not qualify if you...
- Unclassified inflammatory bowel disease.
- History of intestinal resection for IBD other than ileocecal resection.
- Short bowel syndrome.
- Medical treatment needed due to postsurgical recurrence.
- Active perianal disease.
- Medical treatment needed for intestinal stricture.
- Previous participation in IBD medication clinical trials.
- Vigorous physical activity over 6 METs more than 3 days per week.
- Habitual alcohol use over 1 standard drink per day.
- Poorly controlled diabetes mellitus.
- Chronic use of diuretics.
- Chronic kidney disease on dialysis.
- Presence of dependent edema or ascites.
- Having a cardiac pacemaker.
- Pregnant or breastfeeding women.
- Unable to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants undergo bioelectrical impedance analysis to assess body composition.
Periodic visits for bioimpedance analysis assessments
Duration - 24 months
Participants are monitored for changes in body composition over time.
Periodic visits for follow-up body composition assessments
Trial Site Locations
Total: 1 location
1
Unidad de Enfermedad Inflamatoria Intestinal
Barcelona, Spain, 08025
Actively Recruiting
Research Team
A
Antonio Giordano, MD, MSc, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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